Compre Tox

Product NDC
57520-0556
11-digit product format
575200556
Labeler code
57520
Product ID
57520-0556_8d2e5d3f-acba-45de-a296-d6fa7d157906
Type
HUMAN OTC DRUG
Nonproprietary name
Eriodictyon californicum, Hamamelis virginiana, Nymphaea odorata, Plantago major, Xanthoxylum fraxineum, Xerophyllum asphodeloides,
Dosage form
LIQUID
Route
ORAL
Labeler
Apotheca Company
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2010-10-25
Marketing end
0000-00-00
Substance
ERIODICTYON CALIFORNICUM LEAF; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; NYMPHAEA ODORATA ROOT; PLANTAGO MAJOR; ZANTHOXYLUM AMERICANUM BARK; XEROPHYLLUM ASPHODELOIDES; YUCCA FILAMENTOSA; GINGER
Active strength
3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57520-0556IInactivated by FDA2026-10-05
excluded packagepackage57520-055657520-0556-1IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57520-0556-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57520-0556-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57520-0556-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57520-0556-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57520-0556-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57520-0556-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57520-0556-1IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57520-0556-1IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57520-0556-1IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage57520-0556-1IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage57520-0556-1IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage57520-0556-1IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage57520-0556-1IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage57520-0556-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage57520-0556-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage57520-0556-1IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage57520-0556-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage57520-0556-1IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage57520-0556-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage57520-0556-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage57520-0556-1IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage57520-0556-1EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57520-0556-12020-01-31C16284748780-19d75b9d1-2820-f424-e053-dadaa90a57ceCompre Tox

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57520-0556-1Compre Tox60 mL in 1 BOTTLE, DROPPERLIQUID601

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ERIODICTYON CALIFORNICUM LEAFACTIVE INGREDIENT2Y7TIQ135HCOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES,) LIQUID [APOTHECA COMPANY]1
GINGERACTIVE INGREDIENTC5529G5JPQCOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES,) LIQUID [APOTHECA COMPANY]1
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKACTIVE INGREDIENTT7S323PKJSCOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES,) LIQUID [APOTHECA COMPANY]1
NYMPHAEA ODORATA ROOTACTIVE INGREDIENT69RAZ4C432COMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES,) LIQUID [APOTHECA COMPANY]1
PLANTAGO MAJORACTIVE INGREDIENTW2469WNO6UCOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES,) LIQUID [APOTHECA COMPANY]1
XEROPHYLLUM ASPHODELOIDESACTIVE INGREDIENT9I4XB1GP2BCOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES,) LIQUID [APOTHECA COMPANY]1
YUCCA FILAMENTOSAACTIVE INGREDIENTT6VR38UJ9ICOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES,) LIQUID [APOTHECA COMPANY]1
ZANTHOXYLUM AMERICANUM BARKACTIVE INGREDIENTA4KL1HMZ7TCOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES,) LIQUID [APOTHECA COMPANY]1
ERIODICTYON CALIFORNICUM LEAFACTIVE MOIETY2Y7TIQ135HCOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES,) LIQUID [APOTHECA COMPANY]1
GINGERACTIVE MOIETYC5529G5JPQCOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES,) LIQUID [APOTHECA COMPANY]1
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKACTIVE MOIETYT7S323PKJSCOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES,) LIQUID [APOTHECA COMPANY]1
NYMPHAEA ODORATA ROOTACTIVE MOIETY69RAZ4C432COMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES,) LIQUID [APOTHECA COMPANY]1
PLANTAGO MAJORACTIVE MOIETYW2469WNO6UCOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES,) LIQUID [APOTHECA COMPANY]1
XEROPHYLLUM ASPHODELOIDESACTIVE MOIETY9I4XB1GP2BCOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES,) LIQUID [APOTHECA COMPANY]1
YUCCA FILAMENTOSAACTIVE MOIETYT6VR38UJ9ICOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES,) LIQUID [APOTHECA COMPANY]1
ZANTHOXYLUM AMERICANUM BARKACTIVE MOIETYA4KL1HMZ7TCOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES,) LIQUID [APOTHECA COMPANY]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MCOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES,) LIQUID [APOTHECA COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RCOMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES,) LIQUID [APOTHECA COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57520-0556COMPRE TOX (ERIODICTYON CALIFORNICUM, HAMAMELIS VIRGINIANA, NYMPHAEA ODORATA, PLANTAGO MAJOR, XANTHOXYLUM FRAXINEUM, XEROPHYLLUM ASPHODELOIDES,) LIQUID [APOTHECA COMPANY]1Legacy NDC, 1 package rows20101026_58e94551-007d-4e54-b30d-c97924f66a15.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
57520-0556-15752005560160 mL in 1 BOTTLE, DROPPER60 mlHistorical